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NCT06628687 · ClinicalTrials.gov registry record
A Study to Learn How BIIB141 (Omaveloxolone) Affects the Health of Participants With Friedrich's Ataxia Who Took it During Pregnancy and/or During Breastfeeding and About the Health of Their Babies
A clinical trial of Friedreich Ataxia, sponsored by Biogen.
- Recruiting
- Registry status
- 20
- Enrollment target
- 1
- Study location
NCT06628687 is a study of Friedreich Ataxia that is actively recruiting participants, run by Biogen. The registered enrollment target is 20 participants, below the 448-participant average among 14 other Friedreich Ataxia trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06628687, a study of Friedreich Ataxia, is actively recruiting participants, sponsored by Biogen.
- RECRUITING
- Registry status
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
In this study, researchers will learn more about the safety of BIIB141, also known as omaveloxolone or SKYCLARYS. This is a drug available for doctors to prescribe for people with Friedrich's Ataxia, also known as FA. This is known as an "observational" study, which collects health information about study participants without changing their medical care. Participants for this study will have taken BIIB141 at any time during pregnancy and/or while breastfeeding or pumping up through the first year after delivery. Participants can join this study on their own or they may be enrolled by their regular doctors. This study is also known as the "SKYCLARYS (Omaveloxolone) Pregnancy and Lactation Surveillance Program." The main objective of this study is to learn more about how BIIB141 may affect pregnancy, as well as any effects on the health of the mother and of the baby during its first year of life. The main question researchers want to answer in this study is: · Does taking BIIB141 during pregnancy or breastfeeding lead to any major birth defects? Researchers will also learn more about: * Does taking BIIB141 during pregnancy or breastfeeding lead to any minor birth defects? * Does taking BIIB141 during pregnancy or breastfeeding affect the following: * Gestational diabetes, a disease that can happen during pregnancy that affects how your body uses sugar * Pre-eclampsia, a pregnancy-related high blood pressure disease * Unborn baby being small for its expected age (usually in weeks) * Loss of an unborn baby * Live birth * Premature birth * Loss of a newborn * Growth or developmental delays in the baby * Serious illness in the baby resulting in hospitalization * Serious infections in the baby, or ones in babies with a weakened immune system This study will be done as follows: * Participants will join the study after signing an informed consent form, also known as an ICF. * During the study, health information from the participants' regular visits to their doctor wi
Conditions Studied
Interventions
- DRUG Omaveloxolone
Study Locations (1)
North Carolina
- Evidera - Morrisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2026-10-26 |
| Est. Completion | 2035-04-30 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06628687
The ClinicalTrials.gov registry entry for NCT06628687 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 448-participant average among 14 other Friedreich Ataxia trials with a reported enrollment target (96% lower). The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Friedreich Ataxia appearing as the primary indexed condition, and to 1 intervention - of which Omaveloxolone is the first listed.
NCT06628687 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT06628687 about?
NCT06628687 is a clinical study titled "A Study to Learn How BIIB141 (Omaveloxolone) Affects the Health of Participants With Friedrich's Ataxia Who Took it During Pregnancy and/or During Breastfeeding and About the Health of Their Babies". In this study, researchers will learn more about the safety of BIIB141, also known as omaveloxolone or SKYCLARYS. This is a drug available for doctors to prescribe for people with Friedrich's Ataxia, also known as FA. This is known as an "observational" study, which collects health information about...
What is the current status of trial NCT06628687?
This trial is currently recruiting. The enrollment target is 20 participants. The study started on 2026-10-26. Estimated completion is 2035-04-30.
What conditions does trial NCT06628687 study?
This clinical trial studies the following conditions: Friedreich Ataxia.
What interventions are being tested in trial NCT06628687?
The interventions under investigation include: Omaveloxolone (DRUG).
Who is sponsoring clinical trial NCT06628687?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06628687 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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